BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT SWIVEL Y-PIECE

    MDR report key: 1846804 · Received September 28, 2010

    Report

    Report Number
    9611451-2010-00591
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT SOLD IN USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. METHOD: THE COMPLAINT RT029 INFANT SWIVEL Y PIECES ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THIS PRODUCT. RESULTS: WITHOUT ANY COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. CONCLUSION: THE TWO PARTS THAT MAKE UP THE Y-SWIVEL ARE HELD TOGETHER BY A SNAP-FIT, WHICH HAS SOME INHERENT LEAKAGE THAT IS DETECTED AND COMPENSATED FOR BY THE VENTILATOR. IF THE SWIVEL CONNECTIONS ARE NOT PROPERLY TIGHTENED DURING SETUP OF THE CIRCUIT, IT IS POSSIBLE FOR A LEAK TO OCCUR AT THE SWIVEL JOINT. ALL SWIVELS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE SWIVELS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT SOLD IN USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A BOX OF 20 RT029 INFANT SWIVEL WYE PIECES FAILED A LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A BOX OF 20 RT029 INFANT SWIVEL Y-PIECES FAILED THE LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT SWIVEL Y-PIECE BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT029 080918

    Patients

    Seq Age Sex Outcome Treatment
    1